Fully Automated Urine Particle Analyzer UF-5000

Fully Automated Urine Particle Analyzer UF
Fully Automated Urine Particle Analyzer UF-5000 - BN344411

An electrically-powered automated or semi-automated laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electrical detection system based on physical or chemical characteristics, or by detecting immunological markers introduced to the sample during the preanalytical phase and bound via antigen-antibody reactions.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LKM

Device Name: Counter, Urine Particle

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.5200

Third Party Flag: Y

Medical Specialty: HE

Device Id: 04987562440139

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A